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Date: Thursday, May 30, 2024 2:48

Description: Virbac 2013
Release 9.133
Eraquell Oral Paste
 
Species: Horses and other equidae
Therapeutic indication: Pharmaceuticals: Endoparasiticides: Anthelmintics for horses
Active ingredient: Ivermectin
Product:Eraquell Oral Paste
Product index: Eraquell Oral Paste
Withdrawal notes: Horses: Meat and offal = 30 days; Do not use in mares producing milk for human consumption
Incorporating:
Presentation
A white, thick oral paste containing active substance: 1.87 mg/g ivermectin
Uses
Target species
Horses
Indications for use, specifying the target species
Roundworms in the stomach and intestines.
Large strongyles
Strongylus vulgaris: adults and 4th larval (arterial) stages
Strongylus edentatus: adults and 4th larval (tissue) stages
Strongylus equinus: adults
Small strongyles, adults
Cyathostomum spp.
Cylicocyclus spp.
Cylicodontophorus spp.
Cylicostephanus spp.
Gyalocephalus spp.
Hairworms
Trichostrongylus axei: adults
Pinworms
Oxyuris equi: adults and immatures
Ascarids
Parascaris equorum: adults
Intestinal threadworms
Strongyloides westeri: adults
Large-mouth stomach worms
Habronema muscae: adults
Neck threadworms
Onchocerca spp. (microfilariae)
Lungworms
Dictyocaulus arnfieldi: adult and immature
Stomach bots
Gasterophilus spp.: oral and gastric larval stages
Dosage and administration
ERAQUELL paste is given by mouth at the recommended dose rate of 200 micrograms per kg of bodyweight as a single dose. Each syringe division delivers sufficient paste to treat 100kg of bodyweight (corresponding to 1.07g product and 20mg ivermectin).
The syringe containing 6.42 g of paste delivers sufficient paste to treat 600 kg of bodyweight at the recommended dose range.
The syringe containing 7.49 g of paste delivers sufficient paste to treat 700 kg of bodyweight at the recommended dose range.
The horse’s weight should be accurately determined to ensure use of the correct dose of product.
The animal’s mouth should be free of food. The syringe must be placed between the front and back teeth and the paste deposited at the base of the tongue. Immediately elevate the head for a few seconds to ensure that the product is swallowed. Re-treatment should be carried out according to the epidemiological situation and at not less than 30 day intervals.
Contra-indications, warnings, etc
Contraindications
Do not use in dogs or cats as severe adverse reactions may occur.
Do not use in cases of known hypersensitivity to the active substance.
See also “Withdrawal periods”.
Special warnings for each target species
Strategies that should be avoided because they might lead to an increased risk of development of resistance to anthelmintic drugs include:
Too frequent and repeated use of anthelmintics from the same class over an extended period of time.
Underdosing, which may be due to underestimation of body weight, misadministration of the product, or lack of calibration of the dosing device (if any).
Suspected clinical cases of resistance to anthelmintics should be further investigated using appropriate tests. Where the results of the test(s) strongly suggest resistance to a particular anthelmintic, an anthelmintic belonging to another pharmacological class and having a different mode of action should be used.
Resistance to ivermectin has been reported in Parascaris equorum in horses. Therefore the use of this product should be based on local (regional, farm) epidemiological information about susceptibility of nematodes and recommendations on how to limit further selection for resistance to anthelmintics.
Special precautions for use
Special precautions for use in animals
Avermectins may not be well tolerated in all non-target species (cases of intolerance with fatal outcome are reported in dogs, especially Collies, Old English Sheepdogs and related breeds or crosses, and also in turtles/tortoises).
As ivermectin is extremely dangerous to fish and aquatic life treated animals should not have direct access to surface water and ditches during treatment.
Parasite resistance to any particular class of anthelmintic may develop following frequent, repeated use of an anthelmintic of that class.
Since ivermectin is highly bound to plasma proteins, special care should be taken in cases of sick animals or in nutritional conditions associated with low plasma protein levels.
As with all anthelmintics, a veterinary surgeon should establish appropriate dosing programs and stock management to achieve adequate parasite control and reduce the likelihood of anthelmintic resistance.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Do not eat, drink or smoke while handling the product. Avoid contact with skin and eyes. If accidental skin contact occurs, wash the affected area immediately with soap and water. If accidental eye exposure occurs, flush the eyes immediately with water and, if necessary, get medical attention.
Wash hands after use.
Adverse reactions
Some horses carrying heavy infection of Onchocerca microfilariae have experienced reactions with swelling and itching following dosing, assumed to be the result of death of large numbers of microfilariae.
These signs resolve within a few days but symptomatic treatment may be advisable.
Use during pregnancy and lactation
Can be used in pregnant mares. See “Withdrawal periods”.
Interaction with other medicinal products and other forms of interaction
The effects of GABA agonists are increased by ivermectin.
Overdose
Mild transitory signs (slowed pupillary light response and depression) have been seen at a higher dose of 1.8 mg/kg (9 times the recommended dose level). Other signs seen at higher doses include mydriasis, ataxia, tremors, stupor, coma and death. The less severe signs have been transitory. Although no antidote has been identified, symptomatic therapy may be beneficial.
Withdrawal period
Meat and offal : 30 days.
Do not use in mares producing milk for human consumption.
Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Ivermectin is EXTREMELY DANGEROUS TO FISH AND AQUATIC LIFE. . Any unused veterinary medicinal product or waste material derived from such veterinary medicinal product should be disposed of in accordance with local requirements. Do not contaminate surface water or ditches with the product or used containers.
Pharmaceutical precautions
List of excipients
Titanium dioxide E171
Hydrogenated castor oil
Hydroxypropylcellulose
Propylene glycol
Incompatibilities
Not applicable.
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
Shelf-life after first opening of the container: 6 months.
Special precautions for storage
Do not store above 30°C.
Store in the original packaging.
Legal category
Legal category: POM-VPS
Packaging quantities
The product is presented in 6.42 g or 7.49 g plastic syringes made from polyethylene and graduated in 100 kg body weight graduations.
Product presentations
6.42 g syringe: Box of 1, 2, 12, 40 or 48 syringes. Transparent PVC blister sealed onto a carton sheet containing one syringe
7.49 g syringe: Box of 1, 2, 12, 40 or 48 syringes. Transparent PVC blister sealed onto a carton sheet containing one syringe
Not all pack sizes may be marketed.
Further information
Marketing Authorisation Number
Vm 05653/4202
Significant changes
GTIN
GTIN description:Eraquell 7.49g Syringe
GTIN:3597133010893
GTIN description:Eraquell Yard Pack 7.49g Syringe x 28
GTIN:3597133043853